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NCT04474470 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult, sponsored by TyrNovo.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 10
- Study locations
NCT04474470: Completed Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult, sponsored by TyrNovo.
NCT04474470 is a Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult that has completed, run by TyrNovo. The registered enrollment target is 52 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04474470, a Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult, has completed, sponsored by TyrNovo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Primary Outcome
Incidence of treatment emergent adverse events with single agent NT219
Conditions Studied
Interventions
- DRUG NT219
- DRUG NT219 and ERBITUX® - Dose Escalation
- DRUG NT219 and ERBITUX® - Expansion
Study Locations (10)
California
- California Cancer Associates for Research and Excellence - Encinitas
- The Angeles Clinic and Research Institute - Los Angeles
- UCSD Moores Cancer Center - San Diego
Other
- Hadassah University Medical Center - Jerusalem
- Rabin Medical Center - Petah Tikva
- Sourasky Medical Center - Tel Aviv
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Illinois
- The University of Chicago and Biological Sciences - Chicago
Louisiana
- Ochsner Clinic Foundation - New Orleans
Oklahoma
- Stephenson Cancer Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 1 |
What the finished NCT04474470 record still lists
NCT04474470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower).
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which NT219 is the first listed.
NCT04474470 lists 10 locations in 6 states (California, Other, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT04474470 about?
NCT04474470 is a clinical study titled "A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer". This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or ...
What is the current status of trial NCT04474470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-09-03. Estimated completion is 2024-05-08.
What conditions does trial NCT04474470 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Solid Tumor, Adult, Metastatic Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Colorectal Adenocarcinoma.
What interventions are being tested in trial NCT04474470?
The interventions under investigation include: NT219 (DRUG), NT219 and ERBITUX® - Dose Escalation (DRUG), NT219 and ERBITUX® - Expansion (DRUG).
Who is sponsoring clinical trial NCT04474470?
This trial is sponsored by TyrNovo, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04474470 being conducted?
This trial has 10 study locations across California, District of Columbia, Illinois, Louisiana, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04474470's enrollment target sits among peer trials
52 127th of 250 higher than 122 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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